Guidance
University of Michigan Human Research Protection Program Operations Manual (OM)--The OM is designed to illuminate the University of Michigan's overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and others.
Click the Education link, left, for information about IRBMED workshops on IRB forms and policies.
To find guidance on particular topic search for the word on this page using the "Edit" "find" function in the browser toolbar, or use the search box above right, or click on the letter to jump to the alphabetically listings below:
A-B, C-D, E, F-H, I, J-P, N-P, R, S-T, U-Z
A-B
- Accessing Medical Records
- Adverse Event Reporting
- Advertising (see Recruitment Advertising below)
- Amendments
- American Reinvestment and Recovery Act (ARRA) Project Submissions--Instructions
- Assent (see Children, Assent below)
- Belmont Report--Ethical Principles
- Billing (see Clinical Research Billing Unit)
- Blood Draw Guidelines
C
- CareWeb Electornic Signature--Part 11 Compliance Certification
- Certificate of Confidentiality Kiosk (NIH website)
- Children in Research
(also see Neonates for research involving non-viable neonates and neonates of uncertain viablity)
- Assent (pediatric subject's agreement to participate in research)
- Assent Template recommended for children ages 10- to 14-years-old
- Assent Template Announcement
- Assent Guidelines--tool for IRB reviewers and investigators when determining if assent should be required
- HHS Office of Human Research Protections (OHRP) FAQ on child/parent disagreements on partcipation
- National Cancer Institute Guidance (helpful information for all types of research)
- Federal Regulations and Guidance for Children, HHS Office of Human Research Protections (OHRP)
- Federal Regulations for research involving children, HHS Food and Drug Administration (FDA)
- OHRP Frequently Asked Questions
- Research involving greater risk than 'minor increase over minimal' without direct benefit for subjects --OHRP Guidance for 45 CFR 46.407
- Food and Drug Administration 'Pediatric Drug Development' Guidance
- Wards of the State as Research Subjects
- Assent (pediatric subject's agreement to participate in research)
- Clinical Research Billing Unit
- Clinical Trials Registration (ClinicalTrials.gov information)
- Complaints from Subject or Others about a Research Study
- Consent (see Informed Consent)
E
- Eligibility Screening
- Embryonic (human) Stem Cells
- Emergency Use of Test Articles
- For Emergency use of a Humanitarian Use Device see the HUD Guidance
- Emergency Research with Exception from Informed Consent
- eResearch
- Basic Step-by-Step Manuals:
- Electornic Signature--Part 11 Compliance Certification
- Frequently As Questions
- Guidelines for Stacking Documents
- Glossary of eResearch Terms
- Pre-submission Checklist--Things to have, information to gather before starting a submission
- Quick Reference Card
- Tips--Miscellaneous ways to optimize eResearch
- Exempt Research
- Expedited Review
- Expiration Date (see General Guidelines)
F-H
- FDA information about INDs or IDEs see Investigational New Drug Application or Investgational Device Excemption below
- FDA Part 11 CareWeb Compliance Certification
- FDA Part 11 eResearch Electronic Signature Certification
- FDA--University of Michigan Registration with FDA and OHRP--This page provides information frequently requested by sponsors regarding the University's compliance with new registration rules.
- Federal Regulations
- 21 CFR 50 Regulations enforced by the Food and Drug Administration (FDA)-- Protection of Human Subjects
- 21 CFR 56 FDA--Institutional Review Boards
- 45 CFR 46 Regulations enforced by the Department of Health and Human Services Office of Human Research Protections (OHRP)
- OHRP 45 CFR 46 FAQs
- OHRP Federalwide Assurance FAQ
- Fees for IRBMED Review of Sponsored Projects
- Fetuses
- Foster children (see Wards of state)
- General Guidelines
- University of Michigan Human Research Protection Program Operations Manual (OM)--The OM is designed to illuminate the University of Michigan's overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and others.
- Genetic and DNA Based Research
- HIPAA Guidance
- HIPAA and Research - IRBMED Quick Guide
- Helpful Links to Other Sites
- Privacy Board (forms and information)
- Questions about HIPAA
- Humanitarian Use Device (HUD) Guidance
I
- IDE (see Investigational Device Exemption below)
- IND (see Investigational New Drug Application below)
- Informed Consent Guidance
- Approval Dates on Informed Consent Documents
- Children (see above, Children in Research, Assent)
- Emergency Research with Exception from Informed Consent
- Frequently Asked Questions (OHRP)
- Guidelines for Stacking Documents in eResearch
- Non-English Speaking Subjects
- Process
- Reconsenting Study Subjects
- Simplification Guide to Medical Terms (Glossary)
- Telephone (see Telephonic Consent)
- Template-What's New
- Tips on Preparing Understandable Informed Consent Documents
- Waiver under OHRP, FDA & HIPAA Regulations
- Who can Consent or Provide Permission for Participation in Research
- International Research
- IRBMED Help Guide on International Research
- International Compilation of Human Subject Research Protections (PDF document listing the laws, regulations, and guidelines that govern human subjects research in many countries around the world)
- Miscellaneous International Resources at DHHS Office of Human Research Protections (OHRP)
- Investigational Device Exemption (IDE) Application
- Investigational New Drug (IND) Application
- Decision tree to determine an IND is required
- Bioavailability or Bioequivalence Studies--Decision tree to determine if an IND is required
- MICHR IND / IDE Investigator Assistance Program (MIAP)
- Investigator Responsibilities
- HHS FDA Adverse Event Reporting to IRBs (Also see the University of Michigan Required Reporting)
- HHS FDA Guidance--Form FDA 1572, Frequently Asked Questions--Statement of Investigator
- HHS FDA Guidance--Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigator
- HHS Office of Human Research Protections Adverse Event and Unanticipated Problem Reporting (Also see the University of Michigan Required Reporting)
- HHS Office of Human Research Protections FAQs
- MICHR Clinical Research Regulatory Checklist
- University of Micigan Human Research Protection Program, Operations Manual Part 6, Roles and Responsibilities of Investigators and Research Staff
- University of Michigan--Required Reporting: Adverse Events, Other Reportable Information and Occurences, and Unanticipated Problems Involving Risks to Subjects and Others
J-O
N-P
- Neonates
- Office of Human Research Protections (OHRP)--University of Michigan Registration with FDA and OHRP-- This page provides information frequently requested by sponsors regarding the University's compliance with new registration rules.
- Other Reportable Events and Information (ORIO Reporting)
- Payment to Research Subjects
- Prisoners and Research
- Federal Guidance (Office of Human Research Protections (OHRP))
- OHRP FAQs
- New study enrolling prisoners (OVPR webpage)
- Subject becomes a prisoner / Study not previously approved to recruit prisoners seeks to enroll new subject who is a prisoner
- Privacy Board (forms and information)
- Protocol Deviations, Exceptions, Violations
R
- Radiation Exposure Guide
- Reconsenting Study Subjects
- Requesting Medical Records
- Research Billing (see Clinical Research Billing Unit)
- Record Retention--How Long to Research Records
- Recruitment Advertising
- Removal of Blood
- Reports to or from Oversight Agencies, Boards, Committees, etc. (e.g. DSMB, FDA)
- Risk--Guidelines For Using Magnitude Of Harm In Categorizing Risk Level
S-T
- Signatures on Applications
- Standard Operating Procedures (IRBMED)
- Telephonic Consent
- Test Articles in Research
- Biologics and Vaccines
- Charging for Investigational Products
- Investigational Drugs
- General Information
- FDA IND Contact List (to determine if an IND is needed for off-label drug use in research or for a new drug, herb, or nutritional supplement)
- Study Design
- Investigational Devices
- Software Guidance (software may require an investigational device exemption from the FDA)
U-Z
- Unanticipated Problems involving research subjects or others
- Urgent Amendments (Urgency is based solely on urgent health needs of one or more subjects)
- Vulnerable Populations (links to HHS Office of Human Research Protections)
- Wards of the State as Research Subjects
- What's New on Applications
- What's New on the Consent Template
